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Pharmaceutical Preparation - EP3996688

The patent EP3996688 was granted to Merck Patent on Sep 6, 2023. The application was originally filed on Jul 8, 2020 under application number EP20736349A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3996688

MERCK PATENT
Application Number
EP20736349A
Filing Date
Jul 8, 2020
Status
Granted And Under Opposition
Aug 4, 2023
Grant Date
Sep 6, 2023
External Links
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Patent Summary

Patent Family

Patent Family

Patent Oppositions (2)

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CompanyOpposition DateRepresentativeOpposition Status

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STADA ARZNEIMITTELJun 6, 2024KERNEBECKADMISSIBLE
ALFRED E TIEFENBACHERJun 5, 2024HAMM & WITTKOPPADMISSIBLE

Patent Citations (9) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO2009006959
DESCRIPTIONWO2009007074
DESCRIPTIONWO2012028233
INTERNATIONAL-SEARCH-REPORTWO2010078897
INTERNATIONAL-SEARCH-REPORTWO2014067610
INTERNATIONAL-SEARCH-REPORTWO2015104042
OPPOSITIONEP2164843
OPPOSITIONUS2014128396
OPPOSITIONUS2015011534

Non-Patent Literature (NPL) Citations (29) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
OPPOSITION- Anonymous, "c-Met Second-Line Hepatocellular Carcinoma", ClinicalTrials.gov; NCT02115373, (20140414), ClinicalTrials.gov; NCT02115373, URL: https://clinicaltrials.gov/study/NCT02115373, XP093191876-
OPPOSITION- Anonymous, "First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors", ClinicalTrials.gov; NCT01014936, (20170303), ClinicalTrials.gov; NCT01014936, URL: https://clinicaltrials.gov/study/NCT01014936, XP093191880-
OPPOSITION- Anonymous, "Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms", FDA, (19970801), pages 1 - 17, FDA, URL: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070237.pdf, (20160229), XP055253855-
OPPOSITION- Bryan J. Ennis, "Chapter 2:Theory of Granulation: An Engineering Perspective", Bryan J. Ennis, Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, Taylor & Francis , (20050101), pages 7 - 78, ISBN 978-0-8247-2647-8, XP009561235-
OPPOSITION- D25 - In vitro dissolution profiles of tablet formulations representative for Examples 10 and 18 of the patent (EP 3996688)-
OPPOSITION- D26 - Overview of requests filed by Patentee in response to Notices of Opposition-
OPPOSITION- D29a - Curriculum Vitae (CV) of Prof. Dr. Lamprecht-
OPPOSITION- D29 - Expert declaration by Prof. Dr. Lamprecht-
OPPOSITION- Dilip M. Parikh, "Chapter 1, Introduction", Handbook of Pharmaceutical Granulation Technology, Taylor & Francis Group, LLC , (20050101), pages 1 - 6, ISBN 0-8247-2647-2, XP055592603-
OPPOSITION- Johns A., H. Scheible, A. Becker, Jj. Van Lier, M. Meyring, "Open-Label, Single Center, Phase I Trial to Investigate the Mass Balance and Absolute Bioavailability of the Oral C-Met Inhibitor Tepotinib", European Journal of Cancer, (20150901), vol. 51, page S77, XP093192456-
OPPOSITION- Kaur Gurpreet, Manoj Gera, Pallavi Bassi, Ashok K Tiwary, "Roll Compaction/Dry Granulation (Rcdg): Technologies and Their Applications in Drug Delivery and Development", International Journal of Drug Delivery, (20110101), vol. 3, pages 397 - 414, XP093192431-
OPPOSITION- Khokra Ayasha, Khokra Lal, Chandel Abhishek, Prasad Gauri, Sahu Ram Kumar, "Overview on roll compaction/dry granulation process", Pharmacologyonline, (20111101), vol. 3, pages 286 - 298, XP093192444-
OPPOSITION- Lachmann Leon, Herbert A. Lieberman, Joseph L. Kanig, "CHAPTER 11. Tablets", The Theory and Practice of Industrial Pharmacy. 3rd ed., United States , LEA & FEBIGER , (19760101), pages 321 - 358, ISBN 978-0-8121-0532-2, XP093192426-
OPPOSITION- Ritschel, Wolfgang A, Bauer-Brandl, Annette, "Kapitel 4 - passage ", Ritschel, Wolfgang A, Bauer-Brandl, Annette, Wolfgang A. Ritschel ; Annette Bauer-Brandl, Die Tablette : Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Aulendorf, DE, ECV - Editio-Cantor-Verl., (20020101), pages 318 - 319, 372, ISBN 3-87193-228-0, XP009561234-
OPPOSITION- Ritschel, Wolfgang A, "Kapitel 2: Tablettenbestandteile: 2.2 Auswahl der Hilfsstoffe und ihre Einarbeitung", Ritschel, Wolfgang A, Wolfgang A. Ritschel ; Annette Bauer-Brandl, Die Tablette : Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Aulendorf, DE, ECV - Editio-Cantor-Verl., (20020101), pages 63 - 67, ISBN 3-87193-228-0, XP009556297-
OPPOSITION- Rowe Raymond C., Sheskey Paul J, Quinn Marian E,, "Cellulose, Microcrystalline. Isopropyl Alcohol. Magnesium Stearate. Talc", Handbook of Pharmaceutical Excipients Sixth Edition, Php, (20090101), pages 129 - 133, 185-188, 208-210, 227-228, 346-349, 359-378, 404-407, 424-428,525-533, 581-585, 663-666, 728-731, 766-769, ISBN 978-1-58212-135-2, XP093193857-
OPPOSITION- Srikant Pimple, Akash Joshi, Mahesh Digge, "Roller Compaction Design and Critical Parameters in Drug Formulation and Development: Review", International Journal of PharmTech Research, (20140101), vol. 7, no. 1, pages 90 - 98, XP093192448-
OPPOSITION- Wang R, Liu W, Durig T, "Evaluation of different binders for roller compaction", ASHLAND. PHARMACEUTICAL TECHNOLOGY REPORT, (20150101), pages 1 - 5, ASHLAND. PHARMACEUTICAL TECHNOLOGY REPORT, URL: https://www.ashland.com/file_source/Ashland/Product/Documents/Pharmaceutical/PTR_101_Evaluation_of_different_binders.pdf, XP093192428-
OPPOSITION- Wolfgang Ritschel A, Bauer-Brandl Annette, "Tab. 2/1", Die Tablette. Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Editio Cantor Verlaag AULENDORF, (20020101), pages 64 - 65, XP093192421-
OPPOSITION- Andrey G. Ogienko; Elena V. Boldyreva; Andrey Yu Manakov; Vladimir V. Boldyrev; Alexander S. Yunoshev; Anna A. Ogienko; Svetlana A. Myz; Alexei I. Ancharov; Andrey F. Achkasov; Tatiana N. Drebushchak, "A New Method of Producing Monoclinic Paracetamol Suitable for Direct Compression", Pharmaceutical Research, NL , (20110614), vol. 28, no. 12, doi:10.1007/s11095-011-0502-x, ISSN 1573-904X, pages 3116 - 3127, XP019986892
OPPOSITION- Prakash Khadka, Jieun Ro, Hyeongmin Kim, Iksoo Kim, Jeong Tae Kim, Hyunil Kim, Jae Min Cho, Gyiae Yun, Jaehwi Lee, "Pharmaceutical particle technologies: An approach to improve drug solubility, dissolution and bioavailability", Asian Journal of Pharmaceutical Sciences, Elsevier BV, NL, NL , (20141201), vol. 9, no. 6, doi:10.1016/j.ajps.2014.05.005, ISSN 1818-0876, pages 304 - 316, XP055270350
OPPOSITION- Perez-Gandarillas Lucia; Perez-Gago Ana; Mazor Alon; Kleinebudde Peter; Lecoq Olivier; Michrafy Abderrahim, "Effect of roll-compaction and milling conditions on granules and tablet properties", European journal of pharmaceutics and biopharmaceutics, ELSEVIER SCIENCE PUBLISHERS B.V., AMSTERDAM., NL, NL , (20160527), vol. 106, doi:10.1016/j.ejpb.2016.05.020, ISSN 0939-6411, pages 38 - 49, XP029677542
OPPOSITION- Bacher, C. ; Olsen, P.M. ; Bertelsen, P. ; Sonnergaard, J.M., "Compressibility and compactibility of granules produced by wet and dry granulation", International Journal of Pharmaceutics, Elsevier, AMSTERDAM, NL, AMSTERDAM, NL, (20080624), vol. 358, no. 1-2, doi:10.1016/j.ijpharm.2008.02.013, ISSN 0378-5173, pages 69 - 74, XP022698710
OPPOSITION- K.R. Vandana, Y. Prasanna Raju, V. Harini Chowdary, M. Sushma, N. Vijay Kumar, "An overview on in situ micronization technique – An emerging novel concept in advanced drug delivery", Saudi Pharmaceutical Journal, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20140901), vol. 22, no. 4, doi:10.1016/j.jsps.2013.05.004, ISSN 1319-0164, pages 283 - 289, XP055293544
OPPOSITION- Falchook G.S., Hong D.S., Amin H.M., Fu S., Piha-Paul S.A., Janku F., Zheng H., Bladt F., Johne A., Kurzrock R., "First-In-Human Phase I Trial Assessing the Highly Selective C-Met Inhibitor Msc2156119J (Emd 1214063) in Patients with Advanced Solid Tumors", Annals of Oncology, Elsevier, (20140901), vol. 25, no. Suppl. 4, doi:10.1093/annonc/mdu331.10, ISSN 0923-7534, page iv149, XP093192453
OPPOSITION- Falchook Gerald S., Kurzrock Razelle, Amin Hesham M., Xiong Wenyuan, Fu Siqing, Piha-Paul Sarina A., Janku Filip, Eskandari Ghazaleh, Catenacci Daniel V., Klevesath Manfred, Bruns Rolf, Stammberger Uz, Johne Andreas, Bladt Friedhelm, Friese-Hamim Manja, Girard Pascal, El Bawab Samer, Hong David S., "First-in-Man Phase I Trial of the Selective MET Inhibitor Tepotinib in Patients with Advanced Solid Tumors", Clinical Cancer Research, US, (20200315), vol. 26, no. 6, doi:10.1158/1078-0432.CCR-19-2860, ISSN 1078-0432, pages 1237 - 1246, XP093232889
OPPOSITION- Chang Chialu Kevin, Alvarez-nunez Fernando A., Rinella Joseph V., Magnusson Lars-Erik, Sueda Katsuhiko, "Roller Compaction, Granulation and Capsule Product Dissolution of Drug Formulations Containing a Lactose or Mannitol Filler, Starch, and Talc", AAPS PHARMSCITECH, Springer New York LLC, US, US , (20080601), vol. 9, no. 2, doi:10.1208/s12249-008-9088-y, ISSN 1530-9932, pages 597 - 604, XP093192451
OPPOSITION- M. Medová, "Tepotinib. Selective MET receptor tyrosine kinase inhibitor, Treatment of lung and liver cancers", Drugs of the Future, J.R. Prous, (20160101), vol. 41, no. 11, doi:10.1358/dof.2016.041.11.2555984, ISSN 2013-0368, pages 659 - 670, XP009556292
OPPOSITION- Michael Leane, Kendal Pitt, Gavin Reynolds, "A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, NEW YORK, NY, US, US , (20150102), vol. 20, no. 1, doi:10.3109/10837450.2014.954728, ISSN 1083-7450, pages 12 - 21, XP055403462

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